[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654662":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":35,"interventions":47,"overallOfficials":28,"centralContacts":57,"locations":63,"responsibleParty":77,"collaborators":28,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":28,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":28,"overallStatus":98,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Suzhou Immunofoco Biotechnology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of iMagic injection in patients with relapsed\u002Frefractory hematologic malignancies","Incidence of adverse events and its severity after iMagic injection treatment","24 months post iMagic injection infusion",[14,17,20,24,26],{"measure":15,"description":16,"timeFrame":12},"Assessment of pharmacokinetic (about Cmax)","The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)",{"measure":18,"description":19,"timeFrame":12},"Assessment of pharmacokinetic (about Tmax)","The time to reach the maximum concentration (Tmax)",{"measure":21,"description":22,"timeFrame":23},"Efficacy of iMagic injection","Overall response rate after iMagic injection infusion","about 2 years",{"measure":21,"description":25,"timeFrame":23},"Progress-free survival after iMagic injection infusion",{"measure":21,"description":27,"timeFrame":23},"Overall survival after iMagic injection infusion",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"iMagic Injection (IMV101) treatment group","EXPERIMENTAL","iMagic Injection (IMV101) for the Treatment of Relapsed\u002FRefractory Non-Hodgkin Lymphoma",[41],"Biological: iMagic Injection (IMV101)",{"label":43,"type":38,"description":44,"interventionNames":45},"iMagic Injection (IMV102) treatment group","iMagic Injection (IMV102) for the Treatment of Relapsed\u002FRefractory Multiple Myeloma",[46],"Biological: iMagic Injection (IMV102)",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":28},"BIOLOGICAL","iMagic Injection (IMV101)","Eligible patients with relapsed\u002Frefractory non-Hodgkin lymphoma will receive an infusion of iMagic Injection (IMV101) , and the safety and efficacy ofiMagic Injection (IMV101) will be evaluated within 24 months post-infusion.",[37],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":28},"iMagic Injection (IMV102)","Eligible patients with relapsed\u002Frefractory multiple myeloma will receive an infusion of iMagic Injection (IMV102) , and the safety and efficacy of iMagic Injection (IMV102) will be evaluated within 24 months post-infusion.",[43],[58],{"name":59,"role":60,"phone":61,"phoneExt":28,"email":62},"Ning Li","CONTACT","+86-010-87787213","lining@cicams.ac.cn",[64],{"facility":65,"status":28,"city":66,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76],{"name":59,"role":60,"phone":61,"phoneExt":28,"email":62},{"type":78,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100654662","early-phase-1-dose-escalationexpansion-study-of-imagic-in-relapsedrefractory-hematologic-malignancies-100654662",false,"NCT07802756","Dose-Escalation\u002FExpansion Study of iMagic in Relapsed\u002FRefractory Hematologic Malignancies","A Dose-Escalation and Dose-Expansion Study of iMagic Injection in Participants With Relapsed\u002FRefractory Hematologic Malignancies","Inclusion Criteria:\n\n1. Participants voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.\n2. 18\\~80 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. With evaluable tumor lesion.\n5. Relapsed and\u002For refractory hematologic malignancies (Non-Hodgkin Lymphoma or Multiple Myeloma).\n6. Life expectancy≥ 3 months.\n7. Clinical laboratory values meet screening visit criteria.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy.\n2. Prior antitumor therapy with insufficient washout period.\n3. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n4. Lactating women.","ALL","18 Years","80 Years",{"count":90,"type":91},30,"ESTIMATED","INTERVENTIONAL",[94],"EARLY_PHASE1","This is an investigator-initiated, single-center, dose-escalation and dose-expansion early-phase clinical study to evaluate the safety and efficacy of iMagic Injection in participants with hematologic malignancies. The study consists of two cohorts: Cohort 1 enrolls participants with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma, and Cohort 2 enrolls participants with relapsed\u002Frefractory multiple myeloma. Eligible participants in each cohort will receive infusions of iMagic Injection (IMV101 for lymphoma, IMV102 for myeloma). Blood and urine samples will be collected from participants before and after infusion for assessment of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and other relevant evaluations.",[97],"Relapsed\u002FRefractory Hematologic Malignancies","NOT_YET_RECRUITING","2026-09-02",{"date":101,"type":102},"2026-09-08","ACTUAL",{"date":104,"type":91},"2026-09-10",{"date":106,"type":91},"2028-09-10",{"name":5,"class":6},1]